The adjuvanted recombinant zoster vaccine co-administered with a tetanus, diphtheria and pertussis vaccine in adults aged ≥50 years: A randomized trial
Ana Strezova, Himal Lal, Igwebuike Enweonye, Laura Campora, Pierre Beukelaers, Nathan Segall, Thomas C Heineman, Anne E Schuind, Lidia Oostvogels, Ana Strezova, Himal Lal, Igwebuike Enweonye, Laura Campora, Pierre Beukelaers, Nathan Segall, Thomas C Heineman, Anne E Schuind, Lidia Oostvogels
Abstract
Background: This study evaluated immunogenicity and safety of the adjuvanted recombinant zoster vaccine (RZV) and the reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine (Tdap) when co-administered in adults aged ≥50 years.
Methods: In this open label, multi-center study (NCT02052596), participants were randomized 1:1 to the Co-Administration group (RZV dose 1 and Tdap at Day 0 [D0], RZV dose 2 at Month 2 [M2]) or Control group (Tdap at D0, RZV dose 1 at M2, RZV dose 2 at M4). Co-primary objectives were evaluation of the vaccine response rate (VRR) to RZV in the Co-Administration group, and demonstration of non-inferiority of the humoral responses to RZV and Tdap in the Co-Administration compared to Control group. Reactogenicity and safety of RZV and Tdap were also assessed.
Results: VRR to RZV was 97.8% in the Co-Administration group. The non-inferiority criterion was met for the humoral response to RZV and for 4 Tdap antigens, but was not met for the Tdap antigen pertactin. Occurrences of solicited, unsolicited and serious adverse events, and potential immune-mediated diseases were similar between groups.
Conclusions: Co-administration of RZV and Tdap did not interfere with the humoral immune response to RZV or 4 of the 5 Tdap antigens. No safety concerns were identified.
Keywords: Adjuvanted recombinant zoster vaccine; Co-administration; Herpes zoster; Immune response; Reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine; Safety.
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Source: PubMed